José M. Saavedra

Bifidobacterium lactis Bb12 enhances intestinal antibody response in formula-fed infants: A randomized, double-blind, controlled trial

BACKGROUND Addition of probiotics to infant formula may positively affect immune function in nonexclusively breastfed infants. This study aimed to investigate the effect of infant starter formula containing the probiotic Bifidobacterium animalis subspecies lactis (Bb12) on intestinal immunity and inflammation. METHODS Six-week-old healthy, full-term infants (n = 172) were enrolled in a prospective, randomized, double-blind, controlled clinical trial with 2 groups studied in parallel to a breastfed comparison group. Formula-fed (FF) infants were randomized to partially hydrolyzed whey formula (CON) or the same formula containing 10(6) colony-forming units (CFU) Bb12/g (PRO) for 6 weeks. Fecal secretory IgA (sIgA), calprotectin, lactate, and stool pH were assessed at baseline, 2 weeks, and 6 weeks. Anti-poliovirus-specific IgA and anti-rotavirus-specific IgA were assessed at 2 and 6 weeks. RESULTS Among vaginally delivered FF infants, PRO consumption increased (P < .05) fecal sIgA compared to CON. Anti-poliovirus-specific IgA concentration increased (P < .05) in all infants consuming PRO, whereas anti-rotavirus-specific IgA tended to increase (P = .056) with PRO consumption in cesarean-delivered infants. Anthropometrics and tolerance did not differ significantly between FF infants. CONCLUSIONS Infants consuming formula with Bb12 produced feces with detectable presence of Bb12 and augmented sIgA concentration. Furthermore, cesarean-delivered infants consuming Bb12 had heightened immune response, as evidenced by increased anti-rotavirus- and anti-poliovirus-specific IgA following immunization. These results demonstrate that negative immune-related effects of not breastfeeding and cesarean delivery can be mitigated by including Bb12 in infant formula, thereby providing infants a safe, dietary, immune-modulating bacterial introduction.

Early Development of Intestinal Microbiota: Implications for Future Health

Gut microbiota constitute a highly complex ecosystem that interacts with the host and profoundly affects gastrointestinal and systemic immunologic functions. Specific microbial patterns are associated with healthy children and adults, and these patterns are greatly related to the early acquisition of microbes by the newborn and the development of gut microbial communities in the perinatal period. Although direct causation must be firmly established and mechanisms fully elucidated, strong and increasing evidence shows that the early acquisition, development, and maintenance of specific bacterial populations are critical to human health, and a better understanding of these offers great opportunities for intervention.

Patterns of Clinical Management of Atopic Dermatitis in Infants and Toddlers: A Survey of Three Physician Specialties in the United States

OBJECTIVE To describe atopic dermatitis (AD) management patterns in children ≤36 months old as reported by pediatricians, dermatologists, and allergists in the US. STUDY DESIGN A nationally-representative survey was administered to pediatricians (n = 101), dermatologists (n = 26), and allergists (n = 26). Main outcomes included referrals to health care professionals, suggested/ordered laboratory tests, management approach (dietary, pharmacologic, or combination of both) by age, AD location, and severity. RESULTS Significant differences were observed in referrals to healthcare professionals (P < .001). Pediatricians more frequently referred to dermatologists than allergists in mild (52.4% vs 32.0%) and moderate/severe (60.6% vs 38.1%) cases. Dermatologists referred to allergists less frequently for mild (9.1%) than moderate/severe (40.7%) AD cases. Pediatricians (59%), allergists (61.5%), and dermatologists (26.9%) reported treating at least some of their patients with AD with dietary management (infant formula change) alone (with or without emollients). Soy-based formulas were often used. For mild AD, the most commonly reported first-line pharmacologic treatments included topical emollients, topical corticosteroids, and barrier repair topical therapy/medical devices. Over 80% of physicians used a dietary and pharmacologic combination approach. Dermatologists were most likely to manage AD symptoms with a pharmacologic-only approach. AD lesion location influenced pharmacologic treatment in >80% of physicians. CONCLUSIONS Significant and distinct differences in AD treatment approach exist among physicians surveyed. Most pediatricians and allergists use formula change as a management strategy in some patients, whereas dermatologists favor a pharmacologic approach. This diversity may result from inadequate evidence for a standard approach. Consistent methods for managing AD are needed.

Evaluation of Hypoallergenicity of a New, Amino Acid–Based Formula

The American Academy of Pediatrics (AAP) defined a formula as hypoallergenic if it ensures with 95% confidence that 90% of infants with confirmed cow’s milk allergy (CMA) will not react with defined symptoms under double-blind, placebo-controlled conditions. This study’s objective was to determine whether a new amino acid–based formula (AAF) meets the AAP hypoallergenicity criteria. Methods. Children with CMA were randomized to double-blind placebo-controlled food challenges (DBPCFC) with a new AAF and a commercial AAF in crossover fashion followed by an at-home open challenge with the new AAF. Allergic reactions were assessed using a scoring system. Results. Thirty-three subjects completed DBPCFCs with both formulas without acute allergic reactions. The lower bound 95% confidence interval for hypoallergenicity was 91.3%. No unusual stool patterns, allergic symptoms, or signs of intolerance were reported during the open challenge. Conclusion. The new AAF meets AAP hypoallergenicity criteria and can be recommended for the management of CMA.

Growth and Tolerance of Term Infants Fed Formula With Probiotic Lactobacillus reuteri

Background. Lactobacillus reuteri has been studied for its safety and beneficial effects in infants. This study assessed growth of infants fed a partially hydrolyzed whey formula with L reuteri. Methods. Healthy term infants were randomized to 1 of 2 formulas (partially hydrolyzed whey formula with (PRO) or without (CON) L reuteri from 14 to 112 days of age. Anthropometric measures were assessed at 14, 28, 56, 84, and 112 days of age. Tolerance records were completed 2 days prior to each visit. Results. A total of 122 subjects completed study per protocol (60 PRO, 62 CON). No differences were seen in daily weight gain, length, or head circumference. Overall, between groups, there were no significant differences in formula intake, stool frequency, color, consistency, flatulence, frequency of spit-up/vomiting, mood, sleep, or incidence of adverse events. Conclusion. Infants fed probiotic formula had similar growth to infants fed control formula. Both formulas were well tolerated.

Issues Involved in the Process of Developing a Medical Food

The creation of a medical food with potential health benefits for a particular patient population is a surprisingly complex process. Fortunately, the developmental process for a specific medical food is not as rigorous or as tightly regulated as that of a pharmaceutical agent. However, numerous factors unique to the enteral formulation of a new product come into play, such as physical/chemical compatibility, pH, stability, bioavailability, decay, and even palatability. Additional considerations such as strength of health benefit claims, packaging or presentation, and marketability determine the ultimate commercialization and whether a product ends up being released to the public. A full understanding of the development, substantiation, and commercialization of a medical food is necessary for important physiologic concepts in nutrition therapy to end up as part of the therapeutic regimen at the bedside of the critically ill obese patient.

A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared With a Casein-Based Extensively Hydrolyzed Formula

This study compared the growth of healthy infants fed a hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF) with Bifidobacterium lactis (test) with that of infants fed an extensively hydrolyzed casein formula (control). Formula-fed infants (14 ± 3 days) were randomized to test or control groups until 112 days of age. Anthropometrics were assessed at 14, 28, 56, 84, and 112 days, and daily records were kept for 2 days prior to study visits. Serum albumin and plasma amino acids at 84 days were assessed in a subset. A total of 282 infants were randomized (124 test, 158 control). Significantly more infants dropped out of the control (56%) as compared with the test (41%) group. Mean daily weight gain was significantly higher in the test group compared with the control group (27.95 ± 5.91 vs 25.93 ± 6.12 g/d; P = .027) with the test group reporting significantly fewer stools (2.2 vs 3.6 stools/d; P < .0001). The control group reported significantly more days with >3 loose stools/d and a higher incidence of vomiting as compared with the test group. There were no differences in gas, mood, sleep, or serum albumin. Plasma arginine and valine were significantly lower in the test group, whereas leucine and lysine were higher; all values were within normal limits. Significantly more adverse events attributed to the study formula were reported in the control group. The 100% whey-based hypoallergenic EHF containing Bifidobacterium lactis and medium chain triglycerides supported growth of healthy infants. Future studies on the application of this formula in clinically indicated populations are warranted.